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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") APPX 0.22 ML, SMALLBORE PRESSURE INFUSION EXT SET W/MICROCLAVE® CLEAR; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") APPX 0.22 ML, SMALLBORE PRESSURE INFUSION EXT SET W/MICROCLAVE® CLEAR; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-MC330254
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for investigation.
 
Event Description
The customer reported that when disconnecting an iv line from a patient's "j-loop", the inner part of the extension set remained attached to the line and snapped off.The patient began bleeding through the broken set.The staff member clamped the extension set to stop the bleeding.There was patient involvement, but no report of an adverse event or delay in critical therapy.The date of the event is unknown.
 
Manufacturer Narrative
No product samples were returned for investigation.One picture was evaluated and confirmed the reported leak.The cause of the leak cannot be determined.
 
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Brand Name
15 CM (6") APPX 0.22 ML, SMALLBORE PRESSURE INFUSION EXT SET W/MICROCLAVE® CLEAR
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
colonia rancho santa clara, ma
ensenada, b.cfa. 22790
MX  22790
MDR Report Key8450139
MDR Text Key139826172
Report Number9617594-2019-00099
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-MC330254
Was Device Available for Evaluation? No
Date Manufacturer Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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